The legal challenge alleges nonstatutory subject matter under Section 101 of the Patent Act, 35 U.S.C. §101, in that the patents at issue fall within all three of the judicially-recognized exceptions to patentability--natural phenomena, laws of nature, and abstract ideas.

The motion also charges that the claims "constitute patents on thought, knowledge, and ideas in violation of the First Amendment." Finally, plaintiffs add that the claims also violate Art. 1, Sec. 8, Cl. 8 of the U.S. Constitution because they "impede rather than advance science."

The particular patents at issue include claims on the BRCA1 and BRCA2 genes, mutations that are correlated with increased risk of breast or ovarian cancer.

Complaint Against Legality, Constitutionality of Claims.

The original complaint was filed in the U.S. District Court for the Southern District of New York May 12 against the Patent and Trademark Office and Myriad Genetics Inc., co-owner of one patent (5,747,282) and alleged to have an exclusive license for all other patents challenged in the action (8 MRLR 358, 5/20/09).

Several national organizations and preeminent geneticists involved in breast cancer research joined the ACLU and PubPat as plaintiffs.

The complaint adds as defendants 10 individually named directors of the University of Utah Research Foundation, as part owners of all the patents at issue, and charges that Myriad is the sole clinical provider of full sequencing of the BRCA1 and BRCA2 genes in the United States.

The complaint challenges the legality and constitutionality of four categories of claims made or granted by the defendants:

• patent claims over any method, including nonpatented methods, of looking for mutations in natural human genes (5,709,999 patent Claim 1); and

• patent claims over what plaintiffs describe as "the thought" that two genes are different or have different effects, including but not limited to "the thought" that the differences correlate with an increased risk of breast and/or ovarian cancer (5,710,001 patent Claim 1; 5,753,441 patent Claim 1; 6,033,857 patent Claims 1 and 2; '282 patent Claim 20).

Myriad utilizes the patents by marketing a Comprehensive BRCAnalysis test to determine if an individual has mutations in the BRCA1 or BRCA2 genes. According to the complaint, "thousands of doctors and scientists" are capable of determining such a mutation using non-patented methods, but cannot do so "because of the patents on the BRCA1 and BRCA2 genes." Further, the complaint alleges, any doctor performing a nonpatented method "can't tell any patient the results because of Myriad's enforcement of its patents."

The PTO filed a motion to dismiss July 13, arguing that the plaintiffs lack standing (8 MRLR 513, 8/5/09).

Isolation, Transformation to cDNA Insufficient Tests.

The summary judgment motion challenges the PTO's Utility Examination Guidelines, 66 Fed. Reg. 1092 (Jan. 5, 2001) for allowing patents on "isolated" genes, "by which the USPTO means that they have been removed from the body and separated from surrounding cellular material. … 'Isolation' means nothing more than a gene that has been removed from the body and separated from surrounding cellular material, and such a gene is functionally and informationally identical to that in the body."

The motion further challenges those claims that assert a transformation of the gene from DNA into complementary DNA, or cDNA, saying "the cDNA structure simply mirrors the RNA structure in the body, both of which are dictated by nature."

Arguing also that "purification" of genetic material does not create patentable subject matter, plaintiffs rely on a holding from the predecessor to the U.S. Court of Appeals for the Federal Circuit. "[M]ere purification of known materials does not result in a patentable product," according to In re Merz, 25 C.C.P.A. 1314, 1316 (C.C.P.A. 1935), unless "the product obtained in such a case had properties and characteristics which were different in kind from those of the known product rather than in degree."

Thus, the PTO's policy of allowing patents on purified DNA "misses this important distinction," violating the U.S. Supreme Court's holdings on several cases involving biological products, according to the motion. Those cases "hold that patentability requires more than removing a natural product from its environment and purifying it," such as a change in function. But, plaintiffs contend, "Genes are products of nature and sequencing genes does not produce something with a new function."

The plaintiffs argue as well that the patents preempt scientific principles and natural phenomena, inasmuch as "the gene sequence claims in effect patent any use of the BRCA1/2 genes."

Finally on the Section 101 issue, the motion says that claims covering "any method of looking for naturally-occuring mutations in human genes" are directed to an unpatentable abstract mental process, and claims comparing normal and mutated genes "monopolize laws of nature and abstract ideas."

The First Amendment Argument.

The plaintiffs cite the idea/expression dichotomy in copyright law as a basis for their argument that the patents violate the First Amendment. Applying the Supreme Court's more general comments about the effect of the First Amendment in various copyright cases, the motion extends the doctrine to patent law:

The doctrine of patent law that abstract ideas are not patentable is statutory and has not been previously described as compelled by the First Amendment. 35 U.S.C. §101. However, there can be little doubt that patenting of abstract ideas or thought or an entire body of knowledge would violate the First Amendment. …

Because the gene patents in this case directly limit thought and knowledge, they are unconstitutional.

To support their contention, the plaintiffs make separate arguments against "claims for reaching conclusions about the genes" and "claims over the genes themselves."

For six of the claims involving a comparison of gene sequences or growth rates, the motion argues, "The only unique part of these claims is that at the end, the scientist or physician thinks, 'They are the same' or 'They are different' or 'They are different in a way that is significant.' In other words, it is the thought that is patented, not the process."

To the other claims--over the genes themselves--plaintiffs assert that "A genetic sequence is biological information itself," such that the patent claims in this case "limit pure information."

"The defendant USPTO has given entire control over a body of knowledge and over pure information to a private company," according to the motion. "That, under the First Amendment, it cannot do."

The case is assigned to Judge Robert W. Sweet, who set Sept. 10 as the due date for the defendants' response.

Christopher A. Hansen, of the American Civil Liberties Union Foundation, New York, is lead attorney for the plaintiffs. Beth E. Goldman, of the U.S. Attorney's Office in New York, is lead attorney for the government. Myriad Genetics and the Utah Research Foundation directors are represented by Barry R. Satine, of Jones Day, New York.

Amici American Medical Association, American College of Embryology, American College of Obstetricians and Gynecologists, American Society of Human Genetics, and Medical Society of the State of New York, represented by Amy Lynn Katz, New York, filed a brief supporting the plaintiffs Aug. 27.

Amici that have moved to file a brief in the case--Canavan Foundation, Claire Altman Heine Foundation Inc., March of Dimes, Massachusetts Breast Cancer Coalition, National Organization for Rare Disorders, and National Tay-Sachs & Allied Diseases Association--are represented by Mark D. Shtilerman, of Dewey & LeBoeuf, New York.

Another group of amici planning to file a brief includes the Asian Communities for Reproductive Justice, Center for Genetics and Society, Generations Ahead, National Women's Health Network, and Pro-Choice Alliance for Responsible Research, who are represented by Jennifer Lindsay Rubin, of the New York City Law Department Office of the Corporation Counsel, Bronx, N.Y.

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